Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21426 |
| Brand Name: | Asserachrom VWF: CB |
| Model: | |
| Affected: | Lot 114710(RE) |
| Software version: | |
| Recalling Organisation: | |
| Contact Information: | |
| Manufacturer: | |
| Issue: | The Asserachrom® VWF:CB lot 114710(RE) gives higher results compared to the other Asserachrom ® VWF:CB tested lots for samples with a VWF:CB level above 30%. This issue is more pronounced for samples with a VWF:CB level above 50%. Based on our internal testing, Normal samples tested are overestimated by 26% on average (relative deviation). For example: a normal plasma at 134% could be reported at 167%. The pathological samples tested and in particular the type 1 plasmas are overestimated by 38% on average (relative deviation). For example: a type 1 plasma at 56% could be reported at 75%. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 16/5/2017 |
